FOOD SAFETY ASSESSMENT

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FOOD SAFETY ASSESSMENT
Lecture Material - Food Safety Budi Widianarko -
UNIKA SOEGIJAPRANATA
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• PRINCIPLES OF FOOD CONTROL
• (FAO/WHO, 2002)
• Integrated farm-to-table concept
• 2. Risk analysis
• Risk Assessment
• Risk Management
• Risk Communication
• 3. Transparency
• 4. Regulatory Impact Assessment
• the costs of compliance to the food industry,
  as these costs are ultimately passed onto
  consumers

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Recognition of the significant impact of food
borne contaminants (poisonings, diseases etc) in
terms of human suffering and economic costs to
society and industry, combined with an increasing
global food trade has underlined the need for a
structured risk assessment
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HACCP is only one part of the risk analysis
process HACCP is a risk management tool not a
risk assessment tool
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HAZARD a biological, chemical or physical agent
with the potential to cause an adverse health
effect ( e.g. Salmonella could be in food and
it could make someone ill) .............CODEX
definition RISK the likelihood of an adverse
event (e.g. a consumer gets food-borne
illness) and the severity of that
event RISK ? HAZARD
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RISK ANALYSIS RISK ASSESSMENT a process to
scientifically evaluate the probability of
occurrence and severity of known or potential
adverse health effect resulting from human
exposure to foodborne hazards RISK MANAGEMENT a
process to weigh policy alternative in light of
the results of risk assessment and, if required,
to select and implement appropriate control
option RISK COMMUNICATION a process to
exchange information and opinions interactively
among risk assessors, risk managers and other
interested parties
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KASUS (1)Formalin dalam berbagai bahan dan
produk olahan pangan lokalKASUS (2)Melamin
dalam sebuah produk makanan bayi impor

• RISK ASSESSOR
• RISK MANAGER
• OTHER INTERESTED PARTIES

?
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RISK ASSESSOR pihak yang berperan menentukan
keberadaan bahaya dalam pangan dan tingkat
risikonya terhadap kesehatan konsumen RISK
MANAGER pihak yang berperan mengambil tindakan
(mengelola) untuk meminimalkan risiko gangguan
kesehatan karena keberadaan dan paparan bahaya
dalam produk pangan. OTHER INTERESTED
PARTIES semua pihak yang berkepentingan terhadap
risiko kesehatan yang berasal dari bahan/produk
pangan
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WHAT KNOWLEDGE?

• ..

Yes or No WHY?
Yes or No HOW?
Yes or No WHY?
WHAT INFORMATION ?
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BAHAYA
RISIKO
PAPARAN (KONTAK)?
DAMPAK
TAKARAN (DOSIS)? KETAHANAN TUBUH N A S I B
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Renwick et al., 2003
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• A Four-Step Risk Assessment Framework
• 1. HAZARD IDENTIFICATION
• identification of biological/chemical agents that
  are capable of causing adverse health effects and
  may be present in a particular food or group of
  foods
• Information (biological, epidemiological etc) and
  expert knowledge on the link between a
  biological/chemical agent in a specific food and
  illness in consumers

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• 2. HAZARD CHARACTERIZATION
• the qualitative and/or quantitative evaluation of
  the nature of the adverse effects associated with
  biological agents that may be present in food
• Dose response assessment determination of the
  relationship between the numbers of the MO
  ingested (or the concentration of a microbial
  toxin) and the frequency and severity of defined
  adverse health effects resulting from ingestion

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• 3. EXPOSURE ASSESSMENT
• the qualitative and/or quantitative evaluation of
  the likely intake of the biological agent via a
  food
• Estimation of the probability of consumption and
  the amount of biological agent likely to be
  consumed. All sources of entry of the hazard into
  the food should be evaluated.

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• 4. RISK CHARACTERIZATION
• the qualitative and/or quantitative estimation of
  the probability of occurrence and severity of
  known or potential adverse health effects in a
  given population based on hazard indentification,
  hazard characterization/dose-response, and
  exposure assessment
• Combines all the information gathered to produce
  a statement of risk, also includes a summary of
  uncertainties and variability of the information
  used to derive the risk estimate

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Decisions about hazards are essential to control,
reduce, or eliminate requires definition of
limits dictated by acceptable levels of
risk. The notion of an acceptable or
tolerable level of risk is a VALUE-LADEN
concept that must be addressed by policy makers
together with the public.
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FOOD SAFETY EQUATION (H0 - ?R ?I) lt PO (or
FSO)? H0 The Initial Contamination Level ?R
The Sum of Reductions of Contaminant
along the process (from farm to fork)? ?I
The Sum of Increases of Contaminant along
the process (from farm to fork)? PO
Performance Objective FSO Food Safety
Objective
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ICMSF International Commission on
Microbiological Specification for
Foods
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FSO
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DIETARY EXPOSURE ASSESSMENT of Toxic Chemicals
Lecture Material - Food Safety Budi Widianarko -
UNIKA SOEGIJAPRANATA
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CONSUMPTION SAFETYbased on EXPOSURE ASSESSMENT

• Identification of NOAEL/NEL/NOEC based on results
  of toxicity tests (human or other mammals) .
  .Using Toxicological Database
• Application of a safety factor usually 100
• (a quick and dirty method)
• Acceptable Daily Intake (ADI) or Reference Dose
  (RfD)?
• NOAEL no observed adverse effect level
• NEL no effect level
• NOEC no observed effect level

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CONSUMPTION SAFETYbased on EXPOSURE ASSESSMENT
(Contd)?

• 3. (Provisional) Tolerable Weekly Intake
• TWI 7 x ADI
• 4. Estimation of daily or weekly intake (DI/WI)
  of toxicant . based on daily or weekly
  consumption (DC/WC) of the foodstuff and its
  toxicant concentration
• Reference
• e.g. Trace Elements in Human Nutrition and
  Health. WHO FAO. 1996

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CONSUMPTION SAFETYbased on EXPOSURE ASSESSMENT
(Contd)?

• 5. Risk Characterization
• . Calculation of Hazard Quotient (HQ)?
• HQ WI/TWI or HQ DI/ADI
• or HQ DI/RfD
• If HQ gt 1 . there is a significant probability
  that the individuals health will be affected by
  the toxic substance

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CONSUMPTION SAFETYbased on EXPOSURE ASSESSMENT
(Contd)?

• Definitions
• DC daily consumption of the contaminated
  foodstuff (g)?
• WC weekly consumption of the contaminated
  foodstuff (g)?
• DI daily intake of the toxic substance (mg)?
• WI weekly intake of the toxic substance (mg)?
• ADI acceptable daily intake (mg/kg body
  weight)?
• TWI tolerable weekly intake (mg/(x)kg body
  weight)?

Ex. WHO/FAO - female 55 kg (15-60 yrs)?
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QUANTIFICATION OF RISK
WI HQ (1)?
MTWI WI Weekly Intake of metal (µg/kg body
weight)? (weekly consumption of seafood x
concentration of metal in seafood) MTWI
Maximum Tolerable Weekly Intake (µg/kg body
weight)? (WHO, 1996 Cu
Zn Upper Limit of The Safe Range)? The
Cumulative HQ value (Bu-Olayan Al-Yakoob, 1998)?
n k HQ (T) S S
WIij/MTWIij (2)? i1 j1
i 1 . n (index of metal)? j 1 . k
(index of seafood)?
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Weekly Consumption of Seafood (3 coastal
settlements)?
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Weekly Dietary Exposures and Hazard Quotients (1)?
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Weekly Dietary Exposures and Hazard Quotients (2)?
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Weekly Dietary Exposures and Hazard Quotients (3)?
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Tambak Lorok
Tri Mulyo
Tanah Mas
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CURRENT WEEKLY CONSUMPTION LEVEL (WC) 25.9 g
dw/person HQ 1.1 MAXIMUM WEEKLY TOLERABLE
CONSUMPTION (MWTC) CONSUMPTION LEVEL THAT
LEADS TO AN HQ VALUE OF 1.0 MWTC f (HQ,
WC)? MWTC (1/HQ) X WC (1/1.1) 25.9 g
dw/person 23.5 g dw/person
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• THE MELAMINE CASE

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• In summary, excluding infant formula and assuming
  that 50 of the diet is contaminated at a level
  of 2.5 ppm melamine and its analogs, there is a
  1000-fold difference between the estimated
  dietary exposure (intake) and the level of
  melamine that does not cause toxicity in animals
  (NOAEL).  Thus, levels of melamine and its
  analogues below 2.5 ppm in foods other than
  infant formula do not raise public health
  concerns.

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Risk factors in the lifecycle of fermented
sausages
Sources Hoornstra Notermans (2001)
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• SPECIAL FEATURES OF MICROBIAL HAZARDS
• Dynamic of growth
• Inactivation of MOs throughout the food chain
• Diversity of MOs and of human immune
  response to MOs
• The phenomenon of resistance toward
• antibiotics, sanitizers, pasteurization
• Role of the consumer in altering the potential
• risk outcome through food handling and
• preparation

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Repeated Use
Single Use
Growth of bacteria in corned beef during storage
in the refrigerator
Sources Mayasari (2004)
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BUZZ GROUPS